Panel calls for antidepressant warning

Advisory panel says antidepressant drugs should come with warnings about potential suicide risks for children and teens.

December 13 2006: 9:50 PM EST

(REUTERS) -- Antidepressant drugs need warnings that they may raise the risk of suicidal thoughts and behavior in adults up to age 25, a U.S. advisory panel said Wednesday.

The information should be added to current "black box" warnings that say taking the drugs may increase such behavior or thoughts in children and teens shortly after treatment starts, the panel advised the Food and Drug Administration in a 6-2 vote. Antidepressants include Zoloft, made by Pfizer (Charts)., and Eli Lilly's (Charts) Prozac and Cymbalta.

Sales topped $12.5 billion in 2005, according to health information company IMS Health. Some of the drugs come in generic versions.

The panel also endorsed an FDA proposal to note the hazards start declining after age 30 and that the drugs seem to provide protection against suicidal behavior in older patients, particularly after age 65. Several experts on the advisory panel said the warnings should state that untreated depression also can lead to serious consequences, including suicide.

"We want to extend the age in the black box and at the same time not discourage treatment," said panel member Dr. Andrew Leon, a psychiatrist at Weill Medical College of Cornell University in New York.

Weighing the risks

The FDA usually follows recommendations from its advisory panels. The panel deliberations followed testimony from angry and grieving family members who pleaded for strong warnings for all ages. Some said the FDA should have acted when the debate about suicidal behavior first emerged in the early 1990s.

Suzanne Gonzalez said her 40-year-old husband shot himself in the head shortly after he started taking GlaxoSmithKline's (Charts) Paxil. "I hold you all responsible for his death, and I always will," Gonzalez shouted at FDA officials and panelists seated around tables in a hotel meeting room.

"I keep asking myself ... what was my husband thinking? How crazy did you make him that morning that he would get up ... and do this to himself?" she said.

Psychiatrists warned against tough language that may scare patients from treatment. Millions now take antidepressants, but use declined after FDA-ordered warnings in 2004 about suicidal behavior in some youth.

Suicide rates have risen slightly even as prescriptions have fallen, some psychiatrists said. One FDA analysis estimated antidepressants could lead to 14 additional cases of suicidal thoughts or actions among every 1,000 patients treated under the age of 18. For ages 18 to 24, four additional cases could occur.

"A much greater risk of disrupted lives and suicides ... exists with untreated depression," Dr. Darrel Reiger, research director for the American Psychiatric Association, told the panel during public testimony.

Pfizer and Wyeth (Charts) said they had not seen a link between their drugs and suicidal thoughts or behavior in adult trials. Wyeth, which sells the antidepressant Effexor, would support some type of warning on all antidepressants about possible risks for young adults, said Dr. Philip Ninan, vice president for neuroscience at Wyeth's pharmaceutical unit.

Lilly said any warning should note both the risks of untreated depression and the benefits of treatment. Glaxo already has added information from a study showing young adults who took the drug in clinical trials were more likely to report suicidal behavior than those with a placebo.

Stocks of antidepressant makers were little changed or mixed in extended trading. The panel's recommendation for an updated warning came after the close of regular trading.